Device and a method for augmenting heart function

ABSTRACT

A device, a kit and a method are presented for permanently augmenting the pump function of the left heart. The basis for the presented innovation is an augmentation of the physiologically up and down movement of the mitral valve during each heart cycle. By means of catheter technique, minimal surgery, or open-heart surgery implants are inserted into the left ventricle, the mitral valve annulus, the left atrium and adjacent tissue in order to augment the natural up and down movement of the mitral valve and thereby increasing the left ventricular diastolic filling and the piston effect of the closed mitral valve when moving towards the apex of said heart in systole and/or away from said apex in diastole.

RELATED APPLICATIONS

This application is a continuation of and claims priority to U.S. patentapplication Ser. No. 15/928,016 filed Mar. 21, 2018 entitled A DeviceAnd A Method For Augmenting Heart Function, which is a continuation ofand claims priority to U.S. patent application Ser. No. 14/991,863 filedJan. 8, 2016 entitled A Device And A Method For Augmenting HeartFunction (now U.S. Pat. No. 9,999,713 issued Jun. 19, 2018), which is acontinuation of and claims priority to U.S. patent application Ser. No.13/122,394 filed Oct. 18, 2011 entitled A Device And A Method ForAugmenting Heart Function, which is the U.S. National Stage Applicationof and claims priority to International Patent Application No.PCT/SE2011/050338 filed Mar. 25, 2011 entitled A Device And A Method ToControllably Assist Movement Of A Mitral Valve, which claims benefit ofand priority to U.S. Provisional Application Ser. No. 61/317,631 filedMar. 25, 2010, and Swedish application Serial No. SE1050283-9 filed Mar.25, 2010, both entitled Device And A Method For Augmenting HeartFunction, all of which are hereby incorporated herein by reference intheir entireties.

FIELD OF THE INVENTION

The present invention relates to an intra-cardiac blood circulationenhancing apparatus, a system for intra-cardiac blood circulationenhancement and a method for enhancing left ventricular pump function ofa patient. The present invention is in particular applicable to enhancethe pump function of the left ventricle, including as a permanentmeasure for treating a heart failure disease where the heart function isdeficient.

BACKGROUND OF THE INVENTION

Where the heart function is chronically insufficient, there may be aneed to permanently aid the heart function. Heart failure (HF), moreoften called Congestive Heart Failure (CHF), is in general a conditionwhere the heart is unable to support the body tissue with its metabolicdemands and to sustain adequate blood pressure and cardiac output. Theterm Congestive relates to a congestion of blood and fluids in front ofthe pumping ventricles as a result of insufficient forward pumping, mostoften caused by disease of the left ventricle muscle. A peculiarity ofheart cells is that they do not regenerate after damage or cell death,thus conditions have a tendency to worsen rather than heal after heartcell damage. There are many reasons for heart cell death, the mostcommon cause is ischemic heart disease, a condition where the arteriesfeeding the heart muscle get clogged, causing myocardial infarctions(MI). Viruses may damage the muscle cells, and some diseases, forinstance cardiomyopathy have unknown reasons. End stage of long standinghigh blood pressure may also cause end stage heart failure. Heartstrengthening drugs like digoxin or treatment with diuretics help for awhile, but are all only treating symptoms. CHF is a progressiveuntreatable, disabling and finally a deadly condition. According to theAmerican Heart Association homepage, there are in the US at present morethan 5 Million patients living with CHF and 550 000 are added everyyear. 40000 patients in the US are in such a bad state that only a hearttransplant will keep them alive. However, due to the limited number ofsuitable organs only 2500 transplants are done yearly in the US. One mayextrapolate the numbers for the rest of the industrialized world.

Total artificial heart, where the whole native heart is excised andreplaced with a mechanical device was introduced in the 1960's byDeBakey, in the 1980's by among others Jarvik and recently by Copeland(CardioWest, Total Artificial Heart). However, these devices are stillbased on complex designs and are very invasive to install in thepatient. Failure in operation of the device is fatal.

There are other techniques supporting only the failing left ventricle,known as left ventricle assist devices (LVAD). The most popular LVADSare the Novacor and the HeartMate devices. Common for this devices isthe demand for major open heart surgery utilizing extracorporealcirculation by means of a Heart- and Lung-machine while stopping (orexcising) the heart. They are bulky devices, a Novacor weights 1.800grams, a HeartMate 1.200 grams. There are smaller axial flow pumpsavailable nowadays, the HeartMate II, the Jarvik 2000 and the MicroMedDeBakey VAD. However, major open heart surgery is still necessary toinstall and connect these devices to the left ventricle cavity and theaorta by means of large vascular grafts. The mentioned devices havealmost exclusively been used as a bridge to a heart transplant due tohigh frequency of complications, some of which are caused by the largeamount of foreign material, high mortality and limited durability. Theiruse has also been limited because of high prices of up to 150 000 $ onlyfor the device.

In U.S. Pat. No. 5,957,977 an activation device for the natural heart isdisclosed. The activation device has a stint for placement within theinterior volume of a natural heart adjacent cardiac tissue thereof. Thedevice also includes a yoke for placement around a portion of theexterior surface of the natural heart in general alignment with thestint and connected to the stint by at least one cord (surgical thread).By means of multiple parts that are assembled during surgery, a cage iscreated where half of the cage is inside the heart and the other halfoutside. Within the cage a heart chamber, e.g. the left ventricle iscompletely locked in. By means of hydraulic power underneath theexternal part of the cage, compression on the chamber is achieved fromthe outside. The inner half avoids that inner heart structures may giveaway while compressing from the outside. However, the device is veryinvasive, as it requires a connection between the interior of the heartand the exterior of the heart. Moreover, extensive open heart thoracicsurgery is required to position the device in the patient, none of whichinvolves surgery of the mitral valve. Furthermore, the device is notdesigned for action synchronic with the natural heart cycle.

None of the devices for permanent implant previously described arefeasible for minimal invasive catheter based insertion. On the contrary,they all involve major open heart surgery. There is a need and demandfor simpler devices. It is one scope of the here presented invention toomit major cardiac surgery and to allow positioning of an implant withcatheter technique or by minimal access surgery.

Moreover, health care is permanently searching for improved devices andmethods.

Hence, there is a particular need of an improved system and/or methodfor permanently enhancing or assisting left ventricular pump function ofa heart of a patient. The system is advantageously not interfering withthe cardiac cycle of the heart. Major open heart surgery is desired tobe avoided. Even more advantageous would be if at the same time leakingheart valves could be repaired. It is also desired to avoid implantationof large surfaces of foreign material in the heart. Advantageously, thenative valves, like the native mitral valve are preserved, whenenhancing cardiac pump function with such devices.

Hence, an improved system and/or method for permanently enhancing orassisting left ventricular pump function of a heart of a patient wouldbe advantageous and in particular allowing for increased flexibility,cost-effectiveness, long-term function, and/or patient friendlinesswould be advantageous.

SUMMARY OF THE INVENTION

Accordingly, embodiments of the present invention preferably seek tomitigate, alleviate or eliminate one or more deficiencies, disadvantagesor issues in the art, such as the above-identified, singly or in anycombination by providing a device, a system, and a method according tothe appended patent claims.

The here presented innovation is based on improved insight how the leftventricle functions.

Modern imaging of the beating heart has contributed largely to theunderstanding of left ventricle pump action. The pumping force of theleft ventricle has before been understood to be totally a result of theheart muscle contracting and squeezing (systole) around the amount ofblood enclosed inside the left ventricle after closure of the mitralvalve, increasing the pressure and thereby forcing the blood towards theaortic valve, forcing this to open and ejecting the blood into theascending aorta. When the squeezing is completed, an intermission occurs(diastole), during which a new portion of blood enters the leftventricle cavity from the left atrium.

Ultrasound imaging and Magnetic Resonance Imaging (MRI) has revealedthat this previously taught mode of function is not completely true.Instead, one may describe two types of pump action, a long axis and ashort axis action. MRI can show that there is a movement of theatrioventricular mitral valve (MV) plane downwards along the leftventricle long axis that extends from the atrium towards the ventricle'slower end, the apex. The left ventricle muscle cells are pulling thewhole mitral valve plane, including the mitral valve annulus and part ofthe left atrial wall (that is stretching) towards the heart apex. Bypulling the closed mitral valve towards the heart apex, the mitral valvebecomes a piston in a blood displacement pump.

The downwards movement of the mitral valve is in a healthy human up toapproximately 2 centimetres. The downwards movement accelerates theblood column away from the left atrium and towards the aortic valve in acontinuous movement. By means of MRI technology one is able to virtuallymark separate pixels inside the blood column and follow their movement.It is possible to show that the blood column flows more or lesscontinuously from the left atrium to the ascending aorta without everstopping. The blood column is accelerated by the mitral valve pistonmoving up and down along the cardiac long axis, opening every time ittakes a new scoop of blood in an upward movement to the atrium, andclosing just before moving back toward the apex. One may estimate thecontribution of the long axis pump action of the heart to 30-50% of thetotal heart pump function.

In congestive heart failure the downwards movement of the mitral valveis impaired. It is the scope of the here presented innovation to augmentthe long axis function of the heart by means of improving the downwardsand/or upwards movement of the mitral valve. To our knowledge, nobodyhas before attempted to enhance the up- and downwards movement of themitral valve annulus by means of implanting an augmenting device.

The embodiments of the invention provide improved left ventricular pumpaction by means of external power in order to be able to move the nativeMV along the long axis of the left ventricle (LV) towards the heartapex, in synchrony with the cardiac cycle. A synchronized reciprocatingmovement of the MV valve plane is provided by various embodiments.

Major open heart surgery is avoided. Even when surgery would be done toimplant some embodiments of the here presented device, it is limited toaccess the mitral valve annulus and the left ventricle, also providingan opportunity to repair a leaking mitral valve. The here describeddevices, systems and methods do not involve implantation of largesurfaces of foreign material and the native mitral valve is inparticular preserved in some embodiments.

In some embodiments, modern catheter based technology is integrated inthe here described device, system and methods, allowing deployment ofthe whole system or parts of it by means of catheter technique.

According to one aspect of the invention, a medical device is providedfor enhancing intra-cardiac blood circulation of a heart of a patient byassisting left ventricular pump action thereof. The device includes adisplacement unit that controllably moves a mitral valve in a mitralvalve plane substantially along a long axis of a left ventricle of theheart. The displacement unit is further configured to be arranged in thepatient such that the mitral valve is moved in a reciprocating movementduring systole towards an apex of the heart and during diastole awayfrom the apex for assisting the pump action of the heart.

The displacement unit is in use moving the closed mitral valve duringsystole towards the heart apex and/or moving the opening or openedmitral valve during diastole away from the heart apex. The mitral valvethus becomes a supported piston in a blood displacement pump. Thedownwards movement accelerates the blood column away from the leftatrium and towards the aortic valve in a continuous movement. The rangeof movement of the thus supported mitral valve along the long axis is upto approximately 2 centimetres in an adult patient. The range ofmovement is correspondingly less in pediatric patients and especially inpatients with heart failure. The blood column acceleration by the mitralvalve piston is assisted by the displacement unit, helping the mitralvalve plane to move up and down along the cardiac long axis in a desiredmanner. The valve opens every time it takes a new scoop of blood in anassisted upward movement to the atrium, and closes just before assistedmoving back toward the apex in the next systole. The assist movementprovided by the displacement unit is made synchronously with the cardiaccycle to optimize the cardiac assist function provided.

In embodiments the displacement unit has a mechanical unit devised toapply a supporting force to the mitral valve during systole towards theapex, thus augmenting the (still existing) natural pumping force of theheart while ejecting blood into the aorta. In other embodiments thedisplacement unit includes a mechanical unit devised to apply asupporting force to the mitral valve away from the apex during diastole,augmenting the natural filling of the left ventricle of a heart, andthus augmenting the (still existing) natural pumping function of theheart by an improved filling degree. In preferred embodiments theinvention is supporting the systolic as well as the diastolic functionof a heart in synchrony with the heart cycle. The total force suppliedto the mitral valve plane is the combined remaining natural force of theheart and the supporting force provided by the displacement unit.

This enhancement is done in a gentle way by supporting the naturalfunction of the heart. Congestive Heart Failure (CHF) is effectivelytreated or prevented. Long term treatment is enabled. Invasiveness isvery limited. The amount of foreign material implanted in the heart isvery limited. Open heart surgery may not be necessary for installingsome embodiments of the cardiac assist device.

In some embodiments, the mechanical unit has a proximal end at which itis attached to a location of the mitral valve, such as the mitral valveannulus. A distal end is attached to an energy converter unit thattransfers energy from a remote energy source into a linear force and/ora rotational force for providing the supporting force. The mechanicalunit is for instance a pulling and/or pushing unit. The pulling and/orpushing unit is attached to a location in the heart related to themitral valve, such as the mitral valve annulus. The pulling and/orpushing unit is thereby in operation augmenting the natural force of theheart and extends the downwards and upwards movements of the mitralvalve relative the apex. The movement of the MV plane along the longaxis is thus supported, augmenting the natural force of the heart.Alternatively, or in addition, the mechanical unit may be based on othermechanical movement, such as a rotational, threaded, and/or pivotalbased arrangement to provide the supporting force for the cardiacassist.

In some embodiments the mechanical unit is attached to the mitral valveannulus by means of a fixation unit. The fixation unit is for instanceattached in a loop shaped manner, such as circular, along at least aportion of the mitral valve annulus, like an annuloplasty implant. Thefixation unit may have the native form of the annulus circumferencewhere the leaflets are attached. The annuloplasty implant may beprovided in an annular (ring) shape, D-formed shape, open ring C-formedshape, etc. Regurgitation may thus be permanently treated convenientlyby means of repair of a mitral valve. Being part of the displacementunit, heart pumping function is improved in a synergistic manner. Theclosing of the mitral valve leaflets during systole is improved by theannuloplasty, which in turn further improves the efficiency of thesupported pump function provided by the supported displacement of the MVrelative the apex.

Movable units of embodiments, like joints, etc. may be suitablyencapsulated to not be in contact with blood or cardiac tissue to avoidany operational complications.

In some embodiments, the displacement unit has a plurality of magnetictissue anchors that are controllably and selectively magnetic relativeeach other. A first anchor for instance located at the mitral valve, anda second anchor is located remote from the first anchor inside oroutside the heart. This allows for a very compact arrangement withoutmoving parts from a remote energy source. A controlled movement is forinstance achieved by having at least one of the anchors being anelectromagnet that controllably changes polarity synchronized with theheart cycle. One of the magnetic anchors may be a monolithic unit, whichis a combined magnetic anchor and an annuloplasty implant (shape seeabove). Magnetic functionality may be added by a coil unit. The coilunit may be integrated with the annuloplasty implant. Alternatively, thecoil unit may be provided as a flange unit allowing for affixing theannuloplasty implant or anchor unit to the annulus tissue in aconvenient manner.

The second magnet anchor may also be located in the atrial orventricular septum, wherein the second anchor unit may be occluding an(natural) opening in the septum. The occluder anchor may have two flangeunits for apposition to the septum on the left respectively the rightheart side with an interconnecting portion of reduced diameter arrangedin the opening. The occluder anchor is made of a magnetic material orprovided with electromagnetic properties. Septal defects may thus betreated, and heart function is improved conveniently in a synergisticmanner. Septal occlusion and supported MV movement, eventually withreduced regurgitation, provide for optimized heart function.

The second magnet anchor may be located in the left atrial appendage(LAA), wherein the second anchor unit is an LAA occluder. The LAAoccluder may have one or more retention flanges for safe anchoring inthe LAA. The LAA occluder anchor may have two flanges. The occluderanchor LAA is made of a magnetic material or provided withelectromagnetic properties. LAA related diseases, such as embolicevents, may thus be treated conveniently at the same time as supportedheart function is provided. Heart diseases are thus treated in asynergistic manner.

In embodiments the displacement unit is driven by energy from an energysource providing the energy for the movement of the mitral valve in themitral valve plane along the long axis. The energy is e.g. movementenergy that is mechanically transferred from a remote energy source tothe displacement unit. Alternatively, or in addition, the energy iselectrical energy that is transferred from the remote energy source viaa cable to an actuator of the displacement unit.

In the displacement unit the mitral valve may be a replacementartificial valve that is moved along the long axis of the left ventriclereciprocating towards the heart apex and away therefrom in synchronywith the cardiac cycle. Cardiac assist function may then be provided asin other embodiments by providing a movement of the MV plane of thereplacement valve along the LV long axis. Alternatively, the replacementvalve may be arranged to move up and down in a support frame to providethe cardiac assist reciprocating movement along the LV long axis.

In some embodiments an anchor unit of the displacement unit is providedin form of a foldable mitral valve annulus anchor unit affixable to themitral valve annulus. The unit is thus retractable into a catheter andminimal invasive procedures are facilitated.

The displacement unit may be bistable between a stable diastolic upposition and a stable systolic down position of the MV plane, whereinthe displacement unit has an equilibrium state in the up and downposition respectively, and wherein the displacement unit moves betweenthe two stable positions when energy from an external energy source iscontrollably provided to the displacement unit in synchrony with thecardiac cycle. These embodiments may be more energy efficient thanothers.

In embodiments the cardiac assist device has a control unit and a sensorfor measuring physiological parameters related to the cardiac cycleactivity providing a sensor signal. The sensor signal is provided to thecontrol unit which controls the displacement unit to provide themovement by energy from an energy source and based on the sensor signal.The cardiac assist device operation is thus controlled in synchronicitywith the heart action. The sensor may be ECG electrodes or in additionor alternatively be based on detecting one or more other physiologicalparameters related to the cardiac activity, such as a blood pressurewave, acoustic heart sounds, and/or blood flow patterns.

The energy source may be located in tissue under the skin, adjacent to avessel, such as a large vein. This allows for convenient access to thedisplacement unit.

In another aspect of the invention, a kit is provided that includesmedical device of the above aspect of the invention and a deliverysystem for the device. The delivery device may include an introducercatheter with a valve, a guiding catheter, a guide wire and at least onedelivery catheter.

The device and kit may be used in medical procedures.

One medical procedure concerns delivering such a medical device toenhance intra-cardiac blood circulation of a heart of a patient byassisting left ventricular pump action. The method includes providing amedical system including the medical device and an energy source, andsurgically and/or minimally invasively delivering the medical system inthe patient.

The method may include providing a delivery system, such as of theaforementioned kit, for minimally invasively delivering the medicaldevice in the patient, and minimally invasively delivering thedisplacement unit of the medical system in the patient by means of thedelivery system, delivering the energy source, and connecting the energysource and the displacement unit.

The delivery system may include an introducer catheter with a valve, aguiding catheter and a guide wire. The method then may includeintroducing the introducer catheter at a puncture site into the vascularsystem of the patient, inserting the guide wire into the vascular systemvia the introducer catheter, navigating through the vasculature and theheart to a desired site, inserting the guiding catheter over the guidewire, withdrawing the guide wire, through the guide catheter deliveringa first anchor unit at a mitral valve and delivering a second anchorunit at a distance from the mitral valve.

The delivery system may include an introducer catheter with a valve, adelivery catheter and a pushing unit, a guide wire and a guidingcatheter. The method then may include introducing the introducercatheter at a puncture site into the vascular system of the patient,inserting the guide wire into the vascular system via the introducercatheter, navigating through the vasculature and the heart to a deliverysite, inserting the guide catheter over the guide wire, providing ananchor unit at a distal end of the pushing unit, introducing the distalend in front of the pushing unit into the delivery catheter. Thedelivery catheter may have a smaller outer diameter than an innerdiameter of the guiding catheter, and the method includes longitudinallymoving the delivery catheter in the guide catheter. Alternatively, themethod includes retracting the guide catheter, and longitudinally movingthe delivery catheter over the guide wire previously placed at thedelivery site by means of the guide catheter. Further, the methodincludes activating the anchor unit by means of pushing the pushing unitforward while the tip of the delivery catheter has contact with thesurface of delivery site, such as the left ventricle wall, and allowinganchor elements of the anchor unit, such as hooks or blades to dig intothe tissue at the delivery site.

The pushing unit may be a catheter itself, small enough to fit coaxiallyinside the outer delivery catheter. The pushing unit may have a centrallumen allowing the pulling and pushing unit to pass there through allthe way from outside of a patient and through his or hers vascularsystem. The anchor element may have hooks, and be retracted into thedelivery catheter so that the hooks of the anchor are having the tipsfacing forward towards the catheter opening. Alternatively, or inaddition, a separate lumen may be attached, or integrated with, at leastto part of the delivery catheter. The guide wire lumen may also beinside the delivery catheter.

The method may further include threading an extension unit through thedelivery system and releasing a mitral valve annulus anchor byretracting the catheter of the delivery system from over the mitralvalve annulus anchor, and attaching the mitral valve annulus anchor tothe mitral valve annulus.

The method may include providing access to the vascular system bypuncturing a large vein, placing an introducer catheter with a valve inthe vein, through the introducer catheter advancing a guide wire, andover the guide wire advancing a guide catheter to the right atrium,obtaining access to the left atrium by penetrating through an openforamen ovale or through the inter-atrial wall and thereafter advancingthe guiding catheter into the left atrium, and advancing the guidecatheter and the guide wire into the left ventricle through the mitralvalve to the delivery site at the left ventricular wall, advancing adelivery system for an anchor inside the guide catheter or over a guidewire until its catheter opening has contact with the inner surface ofthe left ventricular wall, advancing the pushing catheter and pushingthe anchor out of the catheter opening to dig into the muscular tissueand pull the anchor inside the musculature, and thereby creating asecure anchoring of a pulling and pushing unit, and retracting thedelivery catheter and pushing unit.

The method may include advancing a delivery system for a mitral valveannulus anchor over the pulling and pushing unit until the anchor andits arms are adjacent to the mitral valve annulus, and when in position,retracting the catheter until outside of the patient, allowing arms andtheir attachments hooks to attach to the mitral valve annulus and diginto the tissue.

The method may further include adjusting the pushing and pulling unitand the catheter in length and attaching to the remote energy source.

The method may include positioning the remote energy source in fattytissue under the skin, adjacent to a vessel, such as a large vein as thesubclavian vein, and optionally attaching the energy source to a bonystructure, such as the clavicle.

Some methods may include providing surgical access to the mitral valve,the mitral valve annulus and the left ventricle including surgicallyopening the chest of a human being and establishing extra corporealcirculation (ECC) or manipulating the heart manually from the outside,while still pumping.

The method may include attaching a first anchor unit in the musculaturein the area of the inside left ventricular apex, outside on the leftventricular apex, or in adjacent tissue, attaching a second anchor unitto the mitral valve annulus, and connecting the two anchors to eachother by means of a connecting unit that may shorten and increase thelength between the anchors, attaching the connecting unit to a remoteenergy source. Alternatively, the method may include replacing themitral valve by an artificial valve unit serving as both the mitralvalve and the mitral annulus anchor.

In another aspect, a method is provided for permanently enhancing leftventricular pump function of a heart of a patient, the method comprisingcontrolled assisted mitral valve movement synchronized with a cardiaccycle of the heart.

The method may include providing a medical device adapted to enhanceintra-cardiac blood circulation of a heart of a patient by assistingleft ventricular pump action, the device having a displacement unit, andcontrollably moving a mitral valve in a mitral valve plane substantiallyalong a long axis of a left ventricle of the heart by the displacementunit, wherein the controllably moving includes moving a mitral valve inthe heart in a reciprocating movement during systole towards an apex ofthe heart and during diastole away from the apex for assisting the pumpaction of the heart, and activating the medical device.

The method may include detecting the natural action of the heart, suchas by measuring an electrocardiogram, heart sounds, a blood pressurewave or blood flow of the heart, and providing energy for displacementof the mitral valve in synchrony with the natural heart cycle, therebyenhancing the natural up and down movement of a mitral valve during aheart cycle.

The method may include providing a mitral valve replacement valve forthe movement. The replacement valve may be mounted in a housing, andmoving the heart valve up and down in the housing relative to a mitralvalve annulus attachment.

Moreover, a system is provided for permanently enhancing leftventricular pump function of a heart of a patient, the system includes adisplacement unit for controlled assisted mitral valve movementsynchronized with a cardiac cycle of the heart.

According to another aspect, a computer-readable medium having embodiedthereon a computer program is provided for processing by a computer forpermanently enhancing left ventricular pump function of a heart of apatient, the computer program comprising a code segment forsynchronizing assisted mitral valve movement in relation to the heartapex with a cardiac cycle of the heart.

According to an aspect of the invention, there is provided a kit forpermanently enhancing the left ventricular function of a heart. The kitincludes a left ventricular enhancement or augmentation system placed inthe left ventricle, the left atrium and the mitral valve, and inadjacent tissue able to move the mitral valve plane, its annulus andleaflets along the direction of the long axis of a left ventricle insynchrony with the heart cycle, an energy source and a delivery systemfor carrying the augmentation system to desired positions in the heart.

The kit may provide a convenient package to a surgeon who is about tointroduce an enhancement system into a patient. Thus the kit providesboth implants that may be used for permanently treating the patient anda delivery system which may be used for inserting the implants. Theenhancing means may be pre-mounted in the delivery system for storage,while the energy source may be packaged separately for connection duringsurgery. The kit may further have a guide wire for guiding insertion ofthe delivery system to the desired positions through the vascular systemof a patient. The delivery system may also have a guiding catheter whichis arranged to be pushed over the guide wire to the desired position.Also an introducing catheter for establishing access to the vascularsystem by a percutaneous access may be part of the kit. A valve that isprohibiting blood backflow but still allows a guide wire or a guidingcatheter to pass through is preferably included in the introducingcatheter.

According to a further aspect of the invention there is provided amethod for permanently treating failure of a left ventricle in apatient. The method includes inserting a left ventricular enhancementsystem into the left ventricle, the left atrium and adjacent tissue andarranging an enhancement unit of the enhancement system in desiredpositions such that the enhancement unit may be connected to an energysource unit. The method includes transfer of external energy to theenhancement unit in the left ventricle, the left atrium and adjacenttissue in order to move the mitral valve up and down along an axis fromthe left atrium towards the left ventricular apex, i.e. the long axis,synchronized with the natural heart cycle.

In embodiments, the method includes also insertion of an energy sourceunder the skin.

The method allows for connection of electrical cables or deviceextensions for transferring power to the energy source in such a waythat the energy source may be located under the skin but outside a vein.

Further, the method may involve transfer of electrical energy throughthe skin either by cable or electro-magnetic in order to storeelectrical energy in a battery under the skin.

In addition hereto the method may include the use of computer chips andalgorithms in order to detect the spontaneous cardiac cycle and guidethe enhancing system in accordance to the heart cycle by means ofdetecting an electrocardiogram.

A preferable method of placing an energy source would be to do thissurgically through a small incision in the skin and make a small pocketin the subcutaneous tissue under the skin. Part of the method would beto use the same pocket to gain access to a vein by means of puncturingthe introducer catheter into the vein through the pocket.

Still another part of the method would be to get access to inside of theleft heart by means of puncturing an artery in order to place anchors.

Further it is part of some embodiments of the method to attach an anchorto the inside or walls of the ventricles, the mitral valve annulus orthe atria by means of hooks. An alternative method is to attach ananchor to the wall of the ventricles by inserting it from the outside ofthe heart through a small surgical incision.

Further, parts of the system may be implanted by surgical means whilethe heart is stopped and its function temporarily is provided by aheart- and lung-machine.

Further embodiments of the invention are defined in the dependentclaims, wherein features for the second and subsequent aspects of theinvention are as for the first aspect mutatis mutandis.

It should be emphasized that the term “comprises/comprising” when usedin this specification is taken to specify the presence of statedfeatures, integers, steps or components but does not preclude thepresence or addition of one or more other features, integers, steps,components or groups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which embodiments ofthe invention are capable of will be apparent and elucidated from thefollowing description of embodiments of the present invention, referencebeing made to the accompanying drawings.

FIG. 1 is a partly cross-sectional schematic illustration of a humanheart depicting structures that are involved.

FIG. 2 is a schematic illustration showing the level of the mitral valveplane in relation to the left ventricular long axis.

FIGS. 3A-3C and 4A-4C are schematic illustrations explaining the normalmovement of the mitral valve during a normal cardiac cycle.

FIGS. 5A-5C, 6A-6C, 7A-7C, 8A-8C and 9 are schematic illustrationsdepicting how various embodiments augment the mitral valve movementalong the left ventricular long axis.

FIGS. 10A and 10B are schematic illustrations that describe differentembodiments utilizing pulling and pushing forces in order to augment themitral valve movement.

FIGS. 11A-11C are schematic illustrations that describe differentembodiments utilizing a linear actuator in order to augment the mitralvalve movement.

FIGS. 12A and 12B are schematic illustrations that depict an embodimentusing magnetic force in order to augment the mitral valve movement.

FIGS. 13A and 13B are schematic illustrations which depict an embodimentusing rotational force in order to augment the mitral valve movement.

FIGS. 14A and 14B are schematic illustrations that show a mitral valveand the placement of a mitral valve annulus anchor.

FIG. 15 is a schematic illustration of an artificial heart valvereplacing the native mitral valve when integrated in an embodiment ofthe system.

FIGS. 16A-16C are schematic illustrations of an artificial heart valvein a cage replacing the native heart valve when integrated in anembodiment of the system.

FIGS. 17A-B, 18 and 19 are schematic illustrations of artificial heartvalves when integrated in further embodiments of the innovation.

FIG. 20 is a schematic illustrations that depicts an embodiment forcomplete catheter based implantation of the system.

FIG. 21 is a schematic illustration that shows a remote energy sourcefor embodiments.

FIGS. 22, 23, 24A-24B, 25, 26A-26B and 27 are schematic illustrationsthat show a delivery system for complete catheter based insertion of theheart function augmentation system.

FIGS. 28-30 are schematic illustrations of a method for percutaneouscomplete catheter based placement of the innovation.

FIG. 31 is a flowchart of the method.

DESCRIPTION OF EMBODIMENTS

Specific embodiments of the invention will now be described withreference to the accompanying drawings. This invention may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the invention to those skilled in the art. Theterminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the invention. In the drawings, like numbers refer to like elements.

The embodiments of the invention provide improved left ventricular pumpaction by means of external power in order to be able to move the nativeMV along the long axis of the left ventricle (LV) towards and/or awayfrom the heart apex, in synchrony with the cardiac cycle. The heredescribed permanent implant will not take over or replace the remainingnatural left ventricular pump function, it rather augments the pumpfunction. A synchronized supported up and/or down movement is providedof the mitral valve that works as a piston, when it is closed.

FIG. 1 depicts the anatomical structures of the heart 1, of which atleast some are involved in embodiments of the invention. 2 is theSuperior Vena Cava (SVC), 4 is the right atrium (RA), 6 is the CoronarySinus (CS) ostium, 8 is the CS first part. 10 is the Inferior Vena Cava(IVC), 12 is the Great Cardiac Vein (GCV) at the level of the MV annulus18. 14 is the Left Atrium cavity (LA), 16 is the LA wall, 18 is themitral valve annulus, 19 the whole mitral valve, 20 is the anteriorleaflet and 21 is the posterior leaflet of the mitral valve. 22 is theLV muscular wall, 24 are the papillary muscles connected to the chordae,26 is the apex of the left ventricle. 28 is the aortic valve, 30 theaorta ascendens, 32 the inter-ventricular muscular septum, 34 the leftventricular cavity and 36 the right ventricular cavity. 38 is the rightventricular muscular wall and 40 is the tricuspid valve.

FIG. 2 shows the mitral valve plane 48 in relation to the long axis 49of the left ventricle. As can be seen, the LV long axis 49 is close toperpendicular to the MV valve plane 48.

FIG. 3 is a schematic view of the natural, non-supported movements insystole of the mitral valve plane 48 in relation to the LV apex 26, theMV anterior 20 and posterior 21 leaflets, the MV annulus 18, the aorticvalve 28, the LA wall 16 and the LA cavity 14 during a normal heart beatcycle. The large arrow (x) shows the direction of the blood flow and thesmall arrow (y) the direction of MV plane. In the cardiac cycle, thefollowing moments are shown in FIG. 3 : a) immediately before systole,b) during systole and c) at the end of systole. The piston movement (y)of the mitral valve plane 48 during systole, pushing the blood out ofthe aortic valve 28 can clearly be seen. In a diseased heart, thisnatural systolic movement may be deteriorated. FIG. 4 is a schematicview of the natural, non-supported movements in diastole of the mitralvalve plane 48 in relation to the LV apex 26, the MV anterior 20, andposterior 21 leaflets, the MV annulus 18, the aortic valve 28, the LAwall 16 and the LA cavity 14 during a normal heart beat. The large arrow(x) shows the direction of the blood flow and the small arrow (y) thedirection of the MV plane 48. In the cardiac cycle, the followingmoments are shown in FIG. 4 : a) early diastole, b) late diastole and c)end of diastole. In a diseased heart, this natural diastolic returnmovement may be deteriorated. At the end of diastole the mitral valve isnow closed and ready for the next movement downwards along the long axisof the left chamber in the following systole.

In a diseased heart, for instance, the range of movement of the MV planemay be reduced, e.g. due to heart muscle insufficiencies. Further, othermotion parameters, such as the acceleration and/or maximum velocitycomponent of the MV plane movement may be reduced.

Embodiments as described below assist the remaining natural movement ina diseased heart and thus may provide for an at least partly restorationof the aforementioned motion parameters, such as the range of movementand/or acceleration and/or maximum velocity component of the MV planemovement either during systole, diastole or both.

FIGS. 5 and 6 are schematic views of an embodiment of the invention wheninserted in the heart 1. FIG. 5 depicts, as in FIG. 3 , the movements insystole of the mitral valve plane 48 in relation to the LV apex 26, theMV anterior 20 and posterior 21 leaflets, the MV annulus 18, the aorticvalve 28, the LA wall 16 and the LA cavity 14 during an augmented heartbeat.

A pulling and pushing unit 54 applies a supporting force to the MV. Thepulling and pushing unit 54 forces the MV downwards towards the LV apexduring systole and away from the LV apex during diastole. The supportingforce is generated by means of external power unit 84 and a poweractuator 58 supplied to the pulling and pushing unit 54. The pulling andpushing unit 54 is thereby augmenting the natural force and extends thedownwards movement of the mitral valve 19. The movement of the MV plane48 along the long axis 49 is thus supported, augmenting the naturalforce of the heart. The support makes the cardiac pumping action moreeffective, i.e. cardiac output CO is enhanced. At the same time thecardiac muscle is relieved. The large arrow (x) shows the direction ofthe blood flow and the small arrow (y) the direction of MV plane.

The pulling and pushing unit 54 may in some embodiments either activelypush, pull, or perform both active push and active pull action. Thepulling and pushing unit 54 is then a pulling and/or pushing unit. Thisselection of pulling and/or pushing is done in dependence if assistanceof the MV plane movement is to be provided during systole or diastole orboth. In case only one of the pulling or pushing action is activelyassisting the MV plane movement, the other pushing or pulling action ismade passively (without assisting the natural movement) to return to theinitial position. For instance the MV plane may only be actively movedtowards the LV apex during systole (either by pulling or pushing), andthe return during diastolic filling may passively be made(correspondingly by pushing or pulling) without assisting the naturalmovement.

Embodiments where only the systole or diastole, or portions thereof, areassisted, may provide for reduced energy consumption of the medicalassist device, leading to advantageously enhanced battery life, etc.

The pulling and pushing unit 54 is at the proximal end attached to alocation of the mitral valve, for instance the MV annulus. Attachment ismade by means of a fixation unit 56. The fixation unit 56 is forinstance attached circular along the mitral valve annulus 18, like aloop shaped annuloplasty ring. The other, distal end of the pushing andpulling unit 54 is attached to an energy converter unit 58 thattransfers energy from the remote energy source 84 (not shown) into alinear force. Energy from the remote energy source 84 is in someembodiments provided as electrical energy. A small linear actuator or anelectrical motor is suitable. In the cardiac cycle, the followingmoments are shown in FIG. 5 : a) immediately before systole, b) duringsystole and c) end of systole.

FIG. 6 depicts, as in FIG. 4 , the movements in diastole of the mitralvalve plane 48 in relation to the LV apex 26, the MV anterior 20 andposterior 21 leaflets, the MV annulus 18, the aortic valve 28, the LAwall 16 and the LA cavity 14 during an augmented heart beat. The pullingand pushing unit 54 forces by means of external power 84 (not shown) themitral valve ring along the long axis towards the left atrium, and isthereby augmenting the natural cardiac upward force, extending andsupporting the upwards movement of the mitral valve 19 towards the LA.Thereby the device is enhancing the diastolic filling of the LV beforethe next heart beat. The large arrow (x) shows the direction of theblood flow and the small arrow (y) the direction of MV plane. In thecardiac cycle, the following moments are shown in FIG. 6 : a) earlydiastole, b) late diastole and c) end of diastole, the mitral valve isnow closed and ready for the next systolic downwards movement.

A prototype of the invention was built, using a linear accelerator and acomputer. The computer allowed action in synchrony with anelectrocardiogram. The prototype was tested in an animal experiment. Thechest of a 60 kilogram pig was opened between the ribs. A rod from thelinear accelerator was attached to the mitral valve annulus from theoutside of the heart. The heart function was depressed by means ofdrugs. After activating the device an increase in arterial bloodpressure and cardiac output was observed.

FIGS. 7 and 8 are schematic views of another embodiment when inserted inthe heart 1. The device has two magnetic tissue anchors, namely a first,proximal magnetic anchor 56 and a second, distal magnetic anchor 60. Theanchors 56, 60 are controllably and selectively magnetic relative eachother, allowing for a controlled movement. The first anchor 56 islocated at the MV, e.g. as a loop shaped ring affixed to the MV annulus18. The second anchor unit 60, is located in the LV cavity, e.g. affixedin its wall 22. Alternatively, the second anchor 60 is attached to theLV outer wall. The two anchors are magnets, preferably electromagnets,but one or the other may also be a traditional permanent magnet. Theelectromagnetic magnets are arranged to change polarity, synchronizedwith the heart cycle in order to change between pulling towards eachother and/or pushing away from each other. There are no physicalconnecting units between the anchor units, which allows for an optimalmovement along the LV long axis, which may not entirely be perpendicularto the MV plane. When the anchoring units have different polarity theymove the two anchors closer to each other and correspondingly, when thepolarity is equal, they move the two anchors away from each other. FIG.7 depicts, as in FIG. 3 , the movements in systole of the mitral valveplane 48 in relation to the LV apex 26, the MV anterior 20 and posterior21 leaflets, the MV annulus 18, the aortic valve 28, the LA wall 16 andthe LA cavity 14 during an augmented heart beat. The first magneticanchor 56 (positive charged) and the second magnetic anchor 60 (negativecharged) attract each other and thus by means of magnetic power the twoanchors are attracted closer to each other. This magnetic basedsupporting force is thereby augmenting the natural cardiac muscle forceand the downwards movement of the mitral valve 19 is supported. Thelarge arrow shows the direction of the blood flow and the small arrowthe direction of MV plane, and the magnet 56. In the cardiac cycle, thefollowing moments are shown in FIG. 7 : a) is immediately beforesystole, b) during systole and c) end of systole.

FIG. 8 is a schematic view of the same embodiment as in FIG. 7 indiastole. FIG. 8 depicts, as in FIG. 4 , the movements in diastole ofthe mitral valve plane 48 in relation to the LV apex 26, the MV anterior20 and posterior 21 leaflets, the MV annulus 18, the aortic valve 28,the LA wall 16 and the LA cavity 14 during an augmented heart beat. Themagnetic anchors 56 and 60 now have equal polarity (here both negative)and push each other away. The magnetic power thus forces the two anchorsfrom each other, and is thereby augmenting the natural cardiac force andsupports the upwards movement of the mitral valve 19, namely the MVplane 48 upwards along the long axis 49. The large arrow shows thedirection of the blood flow and the small arrow the direction of the MVplane and the magnet 56. In the cardiac cycle, the following moments areshown in FIG. 8 : a) early diastole, b) late diastole and c) end ofdiastole.

FIG. 9 shows alternative positioning of the second magnet anchor 60. Thesecond anchor 60 can be electromagnetic or classic permanent magnetic.In embodiments where the second magnet 60 is permanent magnetic, thefirst magnetic anchor 56 is an electromagnetic with selectivelyactivatable magnetic polarity. The second anchor 60 can be placed indifferent positions in the heart. However, positions outside the heartare also possible in certain embodiments. Location 61 indicates aposition where the second anchor 60 is not attached to or in the heart.One such position is in the pericardium. Another position is in thepleura or under the skin. Possible alternative attachment sites includethe pericardium, or the diaphragm. The spine or the thoracic cage (ribsand sternum) are also suitable sites for attachment of the second anchor60. Positions 62, 64, 66, 68 indicate positions for the second magnetanchor 60 relative the heart. Position 62 is located in the leftventricle and position 64 is located in the right ventricle. Position 66is located in the RA, preferably in the so called atrial septum betweenthe RA and the LA. One good position is in the foramen ovale of theatrial septum where often an opening is present to the LA. In thisembodiment, the second anchor unit may have the shape of a septaloccluder and provide both septal leakage occlusion and allows forsupport of the cardiac function. Position 68 indicates a position in theLA, again a good attachment site would be the atrial septum, anothergood position in the LA would be the LA appendage (LAA, not shown). Inthis embodiment, the second anchor unit may have the shape of an LAAoccluder and provides both LAA occlusion and allows for support of thecardiac function. These are only examples and a person skilled in theart may think of multiple variations that would work equally well forthe purpose.

Alternatively, or in addition, more than two second anchor units may beprovided accordingly. This may allow for smaller size of each secondanchor unit compared with a single second anchor unit. Alternatively, orin addition, the first anchor unit may comprise a plurality of subunits, allowing for similarly reduced size and implanted mass of eachsub unit compared to a single, integral or monolithic, first anchorunit.

Electrical power for the mini motors, electromagnets or linear actuatorsis in embodiments provided from the remote energy source 84 by means ofinsulated cables 76.

Alternatively, or additionally, in other embodiments, such as shown inFIGS. 10 a and 10 b the energy is transferred mechanically from theremote energy source 84 through an extended connecting unit 73. Theconnecting unit 73 may be arranged as a Bowden cable type, having amovable inner wire surrounded by a sheath 78. The connecting unit 73extends all the way from a tissue anchor 72, through the mitral valveattachment unit 56. The tissue anchor 72 shown here is deployed in theLV muscle wall 22 near the apex 26. The anchor has hooks 75 that diginto the tissue for a strong attachment. One attractive option is todrop the anchor prior to the mitral annulus attachment in order to letit grow into the tissue and create a strong scar tissue beforeconnection to the energy source and starting the action of the device. Agood interval would be to allow ingrowth during 6-8 weeks prior tostarting cardiac assist operation of the device. The guiding sheath 78is at its distal end fixated in the mitral annulus anchor 56 and at itsproximal end at the energy source 84. In this way the following cardiacassist operation is provided. When proximally pulling the connectingunit 73 (relative to the guiding sheath 78), e.g. from an actuator at orinside the energy source, the distance between the tissue anchor 72 andthe MV fixation unit 56 will shorten. When pushing the connecting unit73 (relative to the guiding sheath 78) proximately at the remote energysource, the distance between the tissue anchor 72 and the MV fixationunit 56 increases. In this manner, cardiac assist is provided bysupporting the MV plane 48 movement along the long axis 49. FIG. 10 adepicts the situation when the extended connecting unit 73 is pushedagainst the anchor 72. The mitral valve is then pushed upwards in itsdiastolic position. FIG. 10 b accordingly shows the opposite situationin systole when the extended connected unit 73 is pulled relatively tothe sheath 78. The distal end of the sheath 78 is affixed to the MVfixation unit 56. Thus, the mitral valve is being pushed down insystole, towards the LV apex 26. The mitral valve is thus brought closerto the apex 26, assisting the systolic natural movement of the heart.

Turning to FIG. 11 a , another embodiment is shown where the externalforce is executed by means of an actuator. The electrical power issupplied by the remote energy source 84 (not shown) by means of a cable76. Here the cable connects to the energy source through the vascularsystem. The actuator may advantageously be constructed as a mini linearactuator now available on the market. The actuator may alternatively, orin addition, have a mini motor integrated. MEMS(micro-electro-mechanical-systems) technology may be utilized forconstructing such a motor. Thus FIG. 11 a depicts the situation when theconnecting unit 54 is pushed against the mitral valve annulus attachment56. The mitral valve will then be pushed upwards in its diastolicposition. In FIG. 11 b accordingly, the opposite situation is shown insystole, when the connecting unit 73 is pulled towards the actuator 58.The mitral valve is thus being pulled down in systole and the mitralvalve is brought closer to the apex 26. Here, an electrical cable 76 isconnected to the remote energy source 84 outside the vascular system.

In FIG. 11 c it is illustrated that the axial actuator 58 notnecessarily needs to be arranged inside the LV cavity. As depicted here,it may also be attached to the heart wall close to the apex 26.

FIGS. 12 a-b show examples of configurations described in FIGS. 7, 8 and9 , where electromagnets are used as tissue anchors 56. Furthercombinations of electromagnets and classical permanent magnets will notbe described in relation to separate figures as such combinations willbe apparent for the skilled person when reading the examples givenherein.

In FIG. 12 a , one second anchor unit 60, e.g. a permanent magnet, islocated in the left ventricular wall close to the apex 26. The countermagnet unit, in form of a first anchor unit 56, serves as an attachmentto the mitral valve annulus 18. The first anchor unit 56 is as well anelectromagnet that may change polarity according to the heart cycle. Aknown loop shaped annuloplasty implant may be used with added magneticfunctionality for the first anchor unit 56. Such annuloplasty implantsmay be provided in an annular shape, D-formed shape, open ring C-formedshape, etc. Magnetic functionality may be added by a coil unit. The coilunit may be integrated with the ring, or made easy to attach.Alternatively, the coil unit may be provided as a flange unit allowingfor affixing the implant to the annulus tissue in a convenient manner.

FIG. 12 a depicts the situation in diastole, where both magnetic unitshave the same polarity, here the poles are illustrated positive. Thusthe mitral valve is pushed away from the LV apex, towards the LA. Themitral valve plane is re-positioned upwardly along the LV long axis.Contrary to this, FIG. 12 b shows the situation in systole. The polarityof the magnet unit in the mitral valve has changed polarity, here tonegative, attracting the positive charged magnet unit in the apex andpulling the mitral valve against the apex.

Still another embodiment is now described with reference to FIGS. 13 aand 13 b . Instead of pulling and pushing the extended extension 73, asdescribed above with reference to FIGS. 10 a and 10 b , the force isinstead transferred by means of rotation of the extension unit 73.

A connection unit 79 to the distal anchor 72 allows the extension 73 torotate and/or pivot freely relatively to the anchor 72. Such a pivotingconnection unit may also be provided in other embodiments having aphysical connection between two anchor units, in order to allow for anoptimal movement along the LV long axis, which may not entirely beperpendicular to the MV plane. The connection unit 79 may be a swiveljoint, e.g. a ball joint type of bearing.

The extension unit 73 is provided with threaded windings 80 in the areaof the mitral valve that correspond to mating threaded windings in themitral valve annulus attachment unit 56. By rotating the extension unit73 by means of a suitable actuator powered by the remote energy source84, the mitral valve is forced upwards in diastole as depicted in FIG.13 a . Rotation may be made in counter-clock direction for example. Andcorrespondingly, while rotating the extension unit in the otherrotational direction, here clockwise, as shown in FIG. 13 b , the mitralvalve is in turn forced down along the long axis of the LV towards apex26, as desired in systole.

Movable units of embodiments, like the threaded windings 80, the pivotjoint, etc. may be suitably encapsulated to not be in contact with bloodor cardiac tissue to avoid any operational complications. Alternatively,or in addition, moveable units of embodiments may be covered with drugsthat prohibit blood components attachment that might compromise properoperation. Examples of such drugs are Heparin or cytostatic drugs likeSirolimus, Tacrolimus or any other drug that would avoid such bloodcomponent attachment.

A normal mitral valve is shown in FIG. 14 a . The anterior leaflet ofthe valve 20 is much larger than the posterior leaflet 21. As a resultthereof, the coaptation line 23 (line of contact) where the two leafletsmeet is not in the centre of the valve but rather posterior. In FIG. 14b , a mitral valve annulus anchor 56 is attached to the annulus by meansof sutures 59. The anchor has more or less the native form of theannulus circumference. The pushing and pulling unit 54 and 73 areattached to the anchor by means of an extension unit protruding from theanchor unit 56 towards the coaptation line, like a rod 57. The rod 57 isin this figure shown as being only attached to one position of theanchor 56. The rod 57 may also extend to the other side of the anchor,crossing the entire MV diameter, and be attached here also, as indicatedin FIGS. 10, 11 and 13 . In the illustrated embodiments the attachmentof the pulling and pushing unit 54 and 73 to the mitral valve annulusanchor 56 is made excentric in order to be placed exactly where thecoaptation line 23 is. In this manner, the function of the MV issubstantially not affected. In other embodiments, the pulling andpushing unit 54 and 73 may also be attached to the anchor 56 itself andpenetrate the valve at the annulus, behind preferably the posteriorleaflet of the valve.

The MV may be not working properly, e.g. due to insufficient coaptationof the leaflets. In this case, the geometry of the MV may be correctedin order to re-establish correct coaptation and avoid regurgitation. Inembodiments, the annulus anchor unit 56 may be provided in form of aloop shaped annuloplasty implant correcting the MV function at the sametime as being part of the cardiac assist system, which allows for asynergistic improvement of heart function.

In situations where the mitral valve is so damaged due to disease thatit does not function well, it may be replaced by a replacementartificial valve 100, such as shown in FIG. 15 . The native mitral valvehas been cut away. Here is a biological replacement valve depicted thatis made of bovine pericardium or pig valve tissue treated withGlutaraldehyde. The valve may also be a mechanical artificialreplacement heart valve, not shown here. Leaflets 106 (three in theexample shown in FIG. 16 c ) are mounted in a frame or cage. The frameis preferably made of biocompatible material, such as a suitable metalor plastic. The frame is on its exterior affixed to the MV annulus. Theframe may conveniently be attached to a suture ring 102. The suture ring102 is attached to the mitral valve annulus instead of the anchor unit56, and the pulling and pushing unit 54 and 73 may be attached to thevalve frame instead of the anchor unit 56. Cardiac assist function isthen provided as in other embodiments by providing a synchronizedreciprocating movement of the MV plane of the replacement valve alongthe LV long axis 49.

In still another embodiment, as illustrated in FIGS. 16 and 17 , areplacement artificial valve is received in a housing in which thereplacement valve is arranged to move in the herein described cardiacassist reciprocating movement along the LV long axis. In the illustratedembodiment, a suture ring 102 is provided to be attached to the mitralvalve annulus. A cylinder 104 fits to the size of the suture ring or asealing ring of the valve allowing the valve to move up and down insidethe cylinder, thus acting as a piston. Pushing and pulling unit 54, 73and 78 may be attached to a cage or struts 108 and to struts integratedin the valve 100. FIG. 17 a depicts the valve in an up position duringdiastole and FIG. 17 b in a down position during systole.

With reference to FIG. 18 a cardiac assist device having a replacementvalve is illustrated, where the driving force for the reciprocatingsynchronized movement is electromagnetic. In the illustrated situationthe replacement valve is in the down position in the cage 104. In theexample, this is provided by means of two magnets with identicalpolarity. Opposite polarities moves the valve to the up position. One ofthe electromagnets may be replaced by a permanent magnet.

In FIG. 19 it is illustrated that linear actuators or electro-motors mayalso drive the valve up and down in the housing. Such actuators mayconveniently be integrated into the components of the replacement valveembodiments. Preferably, the actuators are integrated into the housingwith counter elements in the replacement valve.

As can be seen, the replacement valve embodiments do not need a secondanchor unit 72. These embodiments are thus advantageous from that pointof view. However, a remote second anchor unit 72 may alternatively or inaddition be provided in certain embodiments, even with replacementvalves, as the skilled person will readily appreciate from the presentdisclosure.

A complete catheter based version of the cardiac assist system isdepicted in FIG. 20 . As shown here, the anchor unit 56 is provided inform of a foldable mitral valve annulus anchor 110 that may be retractedinside a catheter while being guided through the vasculature to themitral valve and to the mitral valve annulus 18 and then unfolded andaffixed into place. The foldable anchor may have struts 112 that areattached to the mitral valve annulus, e.g. by means of hooks 114. Suchan anchor may also be in the shape of a sling or a foldable ring, notshown. Further minimal invasive embodiments will readily be available tothe skilled person by reading the present disclosure and are notdepicted in detail, except for further embodiments described below withreference to FIGS. 22 to 30 .

In some embodiments the return from the systolic down position of the MVplane to the diastolic up position thereof may be provided at leastpartly in a passive manner. This may be done in several ways. Forinstance, the downward supporting action may be stopped pre-mature atthe end of systole when there is still sufficient pressure in the LV topress the MV plane back towards the diastole up position. When releasingthe supporting force, or a locked position at the end of the systolephase is unlocked, the MV plane is released to move towards the diastoleup position. The timing may be cardiac cycle controlled, e.g. based onECG and/or pressure measurements, in accordance with the descriptionbelow. Alternatively, or in addition, a return spring element may beprovided to support this backwards movement. Alternatively, the systolicposition may be spring biased and only the return to the diastolicposition has to be made against this spring force by suitable actuatorsor magnetic energy. Alternatively, or in addition, the cardiac assistsystem may be provided as a bistable system. Here, the diastolic upposition and the systolic down position of the MV plane may be providedas equilibrium states of the system. Energy is provided from theexternal energy source to initiate the system to move between the twostable positions. These embodiments may be more energy efficient thanothers.

Permanent magnets in embodiments may be conventional iron magnets.Alternatively, super magnets, like Neodymium rare earth magnets may beused to improve efficiency and/or reduce size of the units of thecardiac assist system, when comprising magnetic elements.

Several actuating principles may be combined with each other in certainembodiments, e.g. a linear actuator and magnetic driving.

A remote energy source 84 is shown in FIG. 21 . It has a battery section86 and a computing section 88 containing computer algorithms and chips.The computer section 88 has receiving electrodes or surfaces 92connected, which are able to detect an Electrocardiogram (ECG) signal.Based on the ECG signal, the cardiac assist device operation is inembodiments controlled in synchronicity with the heart action. Suchsynchronicity may in addition or alternatively be established by meansof detecting other physiological parameters related to the cardiacactivity. Such parameters include a blood pressure wave or blood flowpatterns.

Alternatively, or in addition, the assisted mitral valve movement may becontrolled according to a set sequence of reciprocating movements of theMV plane that mimics the natural cardiac cycle to optimize the cardiacassist function. Frequency, speed, and duration of different pause timesof the reciprocating movement may be set in the sequence to mimic anatural or desired movement. The different parameters, such as pausetime duration of the movement, may vary over any time interval, and maybe set to vary according to a repeating program. The sequence may beprogrammed into the computing section/control unit 88 which controls thedisplacement unit. The displacement unit may then provide the assistedmovement according to the set sequence. Energy from an energy source 84may thus be controllably provided to the displacement unit according tothe set sequence for providing the assisted movement.

Alternatively, or in addition, the medical device may be incorporatedinto an artificial pacemaker system controlling or assisting the naturalcardiac muscle function. For instance the assisted movement of thecardiac assist device may be controlled from a processing unit of apacemaker. The pacemaker including the processing unit may be implantedin a patient. The pacemaker triggers heart muscle activity in a per-seknown manner, e.g. via leads connected to the cardiac tissue forartificially triggering the cardiac activity. Triggering of the assistedmovement of the cardiac assist device may be controlled may be based onthe electrical triggering of the cardiac activity by the artificialpacemaker system, which is already synchronized with the cardiac cycle.Preferably a time delay is provided from triggering electricaltriggering of the heart muscle activity to the triggering/activation ofthe assisted movement of the cardiac assist device during a heart cycle.The amount of the time delay may be optimized, depending on the transfertime of electrically triggering the heart muscle activity and theresulting pump function of the heart caused by the controlled heartmuscle contraction.

The remote energy source 84 may have a mechanical section 90, whererotational or linear motion may be transferred to extension unit 73.Rotational movement may be transferred directly from an electricalmotor, or geared down in revolutions by a gear-box. Rotational energyfrom an electrical motor may be converted to linear movement, enablingpulling and pushing force to a wire connecting unit 73 that is extendingall the way to the distal anchor position. Alternatively, or inaddition, the mechanical section 90 may contain other actuators. Forinstance one or more strong electromagnets may be provided in anactuator that alternately are able to provide pulling and pushing forceto a wire connecting unit 73 that is extending all the way to the distalanchor position. Further, the pulling and pushing force from the remoteenergy source 84 may also be achieved by means of a linear acceleratorin the mechanical section 90. Alternatively, or in addition, themechanical section 90 contains an actuator providing pulling and pushingforce to a wire 73 that is extending all the way to the distal anchorposition by means of electrically alternately cooling and warming aNitinol actuator as commercially available from MIGA Motor Company,Modern Motion, www.migamotors.com. Finally, in other embodiments, theremote energy source is without a significant mechanical section,instead computer chips are distributing electricity from the batteryaccording to the detected physiological parameter signal either toelectromagnets in one or more of the anchor units of the implantedcardiac assist device or to mini-motors or linear actuators in a heartchamber or on the heart surface as previously described, or to actuatorsin the housing 104 in FIG. 19 , etc.

The remote energy source may have a rechargeable battery that e.g. ischarged by means of a wire 94 penetrating the skin and when charging thebattery connected to a charging device externally (not shown). Chargingmight also be done wireless through the skin, e.g. by means ofelectromagnetic coils transferring energy inductively. The skilledperson in the art may alter and design such charging according tospecific requirements and available actual technology.

In some particular embodiments, the remote energy source is located inthe fatty tissue under the skin, adjacent to a vessel, preferably alarge vein. This allows for convenient access to the heart.Alternatively, the energy source may be attached to a bony structure,such as the clavicle (not shown), in order to prohibit dislocation ofthe same when delivering mechanical energy to the cardiac assist deviceinside the heart. A pocket 95 in FIG. 28 in the subcutaneous tissue maybe created close to the actual vessel, here the subclavian vein 3 inFIG. 28 .

A delivery system and a method 800 for complete catheter based insertionof the augmentation system are shown in the FIGS. 22-31 .

The delivery system has an introducer catheter 120 with a valve, aguiding catheter 122, a guide wire 124 and delivery catheters 126 and128. FIG. 22 shows the guiding catheter that has a smaller outerdiameter than the inner diameter of the introducer catheter to fitinside. By means of the guiding catheter 122 and the guide wire 124 onemay navigate through the vasculature and the heart to the desired sitefor delivering either a distal anchor 72 or a foldable mitral valveannulus anchor 110. All catheters described in the system are made ofsynthetic material usually used for medical catheters for interventionalprocedures in the vascular system. Typical such materials are polyvinyl,polychloride, polyethylene, polyurethane and other polymers.

A delivery system for the anchor unit 72 is shown in FIGS. 23-25 . FIG.23 shows a delivery system comprising an outer catheter 130 and apushing unit 132. The pushing unit 132 is a catheter itself, smallenough to fit coaxially inside the outer delivery catheter 130. Thepushing unit 132 has a central lumen allowing the pulling and pushingunit 73 to pass there through all the way from outside of a patient andthrough his or hers vascular system.

The anchor unit 72 is illustrated in FIG. 23 being retracted into thedelivery catheter so that the hooks 75 of the anchor are having the tipsfacing forward towards the catheter opening.

In FIG. 24 two alternative two methods are depicted for navigating thedelivery systems 126 and 128. In FIG. 24 a , the delivery catheter 130has a smaller outer diameter than the inner diameter of the guidingcatheter 122 and may thus travel longitudinally inside the latter. InFIG. 24 b the delivering of the anchor 72 is made without the guidingcatheter 122 in place, instead the delivery system 126 is running over aguide wire 124 previously placed at the delivery site by means of theguiding catheter 122 that subsequently has been retrieved before deviceinsertion. A separate lumen 132 is attached, or integrated with, atleast to part of the delivery catheter 130, in other embodiments theguide wire lumen may be inside the delivery catheter (not shown).

In FIG. 25 , delivery system 126 for the distal anchor is shown beingactivated by means of pushing the pushing unit 132 forward while the tipof the delivery catheter has contact with the inner surface of the leftventricle wall 26, allowing the hooks or blades 75 to dig into themuscular tissue.

In FIG. 26 , a delivery system 128 for the mitral valve annulus anchor110 is shown. Previously it has been described that the mitral valveannulus anchor 110 is attached to the distal end of catheter 78. Thepulling and pushing unit 73 is attached distally to the left ventricularwall by means of anchor 72 and extend through delivery catheter 134 andthrough the catheter 78 to outside of the patient and its vascularsystem. The extension 73 is thread through the delivery system 134 bythe operator after deployment of distal anchor 72 as described.Releasing the mitral valve annulus anchor 110 is done by retracting thecatheter 134 of the delivery system from over the anchor 110 that mayattach to the mitral valve annulus 18. FIG. 27 show both anchors 72 and110 deployed. By pulling or pushing 72 relatively to 110 the mitralvalve may be moved up and down relatively to the apex of the heart insynchrony with the cycle of the heart, wherein the movement control ise.g. based on ECG.

A method for permanently augmenting the heart pumping function by meansof assisted mitral valve movement based on complete catheter basedtechnology is described with reference to FIGS. 28-31 . FIG. 28 showsthe heart and the great vessels of a human being, and FIG. 29 the rightand left atrium, the atrial septum 7, foramen ovale 5 and the mitralvalve 19. Preferably access to the vascular system is made in step 810by puncturing a large vein, shown here is the subclavian vein 3, but anyother large vein might be used, for instance the femoral vein in thegroin. An alternative, is a route through the arterial system for accessis depicted in FIG. 30, 39 is the iliac or femoral artery and 37 theabdominal and thoracic aorta. Only the vein access will be describedhere: An introducing large catheter 120 with a valve (in order toprohibit blood spill) is placed in the vein. Through the introducercatheter a guide wire 124 is advanced, and over the guide wire a guidecatheter is advanced in step 820 to the right atrium 4. From here accessis obtained to the left atrium 14 either by penetrating an open foramenovale (a native opening between the two atria), or by means of pushing aneedle (not shown) through the inter-atrial wall 7 and thereafteradvancing the guiding catheter over the needle extension into the leftatrium 14. Further, the guide catheter 122 and the guide wire 124 areadvanced into the left ventricle through the mitral valve 19. Once theguide catheter has contact with the left ventricular muscular wall atthe desired site, the delivery system 126 for the anchor 72 is advancedinside the guide catheter or over a guide wire 124 in step 830 until itscatheter opening has contact with the inner surface of the leftventricular wall 26. By means of advancing the pushing catheter 132, thetips of the hooks or blades 75 of anchor 72 will dig into the musculartissue and pull the anchor inside the musculature an thereby create ansecure anchoring of the pulling and pushing unit 73. The inventor has onseveral occasions placed such anchors into the left ventricularmusculature in animal experiences and observed the hooks pull themselvesinto the tissue. In one embodiment of the method, the anchor is allowedto heal into the musculature by scar tissue over a period of preferably6-12 weeks before the cardiac assist system is activated. In animalexperiments the inventor has found such scar attachment stronger thanthe musculature itself, and by pulling 1.5 to 2 kilogram force wasnecessary to pull the anchor out, and then only together with the scartissue.

Once the anchor has been deployed, catheters 130 and 132 are retractedfrom the patient over the pulling and pushing unit 73. Now the deliverysystem 128 for the mitral valve annulus anchor 110 is advanced over thepulling and pushing unit 73 in step 840 until the anchor 110 and itsarms 112 are adjacent to the mitral valve annulus. When in position, thecatheter 134 is retracted over the catheter 78 until outside of thepatient. The arms 112 and their attachments hooks 114 are allowed toattach to the mitral valve annulus and dig into the tissue in step 850.Again the same healing in period of preferably 6-12 weeks beforeactivation of the system as already described may be applied. Otherfoldable slings or rings may be used instead the arms described ofanchor 110. A person skilled in the art of catheter based technologiesmay use other methods for attachments, still being within the scope ofthis innovation. Once both anchors 72 and 110 are securely attached, thepushing and pulling unit 73 and the catheter 78 are adjusted in lengthand attached to the remote energy source 84 in step 860, and the systemmay be activated in step 870. The remote energy source has a unit todetect the natural action of a heart, e.g. based on anelectrocardiogram, a blood pressure wave or blood flow. The remoteenergy source may thus provide energy for the distance change betweenthe two anchors in synchrony with the natural heart cycle, therebyenhancing the natural up and down movement of a mitral valve during aheart cycle.

A surgical method for permanently augmenting the heart pumping functionby means of assisted mitral valve movement based on surgical technologyis described with reference to FIGS. 10-19 and 21 . Surgical access tothe mitral valve, the mitral valve annulus and the left ventricle isachieved by means of surgically opening the chest of a human being andestablishing extra corporeal circulation (ECC) using a heart- and lungmachine (HLM). One anchor unit is attached in the area of the leftventricular apex, in the musculature, on the left ventricular apexoutside or in adjacent tissue. A second anchor unit is attached to themitral valve annulus, preferably by means of suturing, but also clips orhooks or other suitable methods for attachment may be used. The twoanchors are connected to each other by means of connecting unit that mayshorten and increase the length between the anchors. The connecting unitis attached to a remote energy source. The remote energy source hasmeans to detect the natural action of a heart e.g. in the form of anelectrocardiogram, a blood pressure wave or blood flow. The remoteenergy source may thus provide energy for the distance change betweenthe two anchors in synchrony with the natural heart cycle, therebyenhancing the natural up and down movement of a mitral valve during aheart cycle. Analog to the here described surgical method, one magneticanchor may be attached to the mitral valve annulus in a similar way,while a second magnetic anchor is attached to left ventricularmusculature or elsewhere in the heart, or adjacent to the heart asdescribed above. The remote energy source has means to detect thenatural action of a heart e.g. in the form of an electrocardiogram, ablood pressure wave or blood flow. The remote energy source may thusprovide electrical energy through leads to the magnets in order tocharge the magnets and change the polarity of the magnets, therebyproviding energy for the distance change between the two magneticanchors in synchrony with the natural heart cycle, thereby enhancing thenatural up and down movement of a mitral valve towards and away from theapex of the heart during a heart cycle.

In another embodiment of a surgical method, the native heart valve isreplaced by an artificial valve serving as both the mitral valve and themitral annulus anchor.

In still another surgical method for using the invention, an artificialheart valve is mounted in a cage or housing, allowing the heart valve tomove up and down relatively to the mitral valve annulus attachment bymeans of the remote energy source as described.

Finally in a further embodiment of the surgical method, access to theheart is achieved by surgically opening the chest. Without the use ofECC the device insertion to the heart structures is done by means ofmanipulating the heart manually from the outside, while still pumping.

Concurrently filed patent application titled “A DEVICE, A KIT AND AMETHOD FOR HEART SUPPORT” claiming priority to U.S. ProvisionalApplication Ser. No. 61/317,619 filed Mar. 25, 2010, and Swedishapplication Serial No. SE1050282-1 filed Mar. 25, 2010, both entitledDevice, a Kit and a Method for Heart Support, of the same applicant asthe present application, which are all incorporated herein by referencein their entirety for all purposes. This co-pending applicationdiscloses devices and methods for permanently augmenting the pumpfunction of the left heart. The mitral valve plane is assisted in amovement along the left ventricular long axis during each heart cycle.The very close relationship between the coronary sinus and the mitralvalve is used by various embodiments of a medical device providing thisassisted movement. By means of catheter technique an implant is insertedinto the coronary sinus (CS), the device is augmenting the up and downmovement of the mitral valve and thereby increasing the left ventriculardiastolic filling and the piston effect of the closed mitral valve whenmoving downwards for augmenting the left ventricular pumping effect.Embodiments of the present disclosure may be combined with embodimentsof the co-pending application. For instance an annuloplasty ring may meprovided as a mitral valve intra-atrial or intra-ventricular anchor unitwith a CS anchor unit or driving unit as described in the co-pendingapplication. A prosthetic artificial MV may be provided in combinationwith CS anchor unit or driving unit, etc. The MV plane mayadvantageously be well mechanically and stable be provided and movedmore efficiently by some of these combined embodiments.

The present invention has been described above with reference tospecific embodiments. However, other embodiments than the abovedescribed are equally possible within the scope of the invention.Different method steps than those described above, performing the methodby hardware or software, may be provided within the scope of theinvention. The different features and steps of the invention may becombined in other combinations than those described. The scope of theinvention is only limited by the appended patent claims.

What is claimed is:
 1. A device adapted to enhance intra-cardiac bloodcirculation of a heart of a patient by assisting pump action of saidheart, said device comprising: an annulus attachment for fixating an endof said device to a cardiac valve annulus, said annulus attachmentconnected to an actuator via an extension including a rod to apply amechanical supporting force to the valve annulus towards an apex of saidheart during at least a portion of systole for augmenting a naturalpumping force of the heart, and/or away from said apex of said heartduring at least a portion of diastole for augmenting a natural fillingof a ventricle of said heart; wherein said annulus attachment has ashape selected from the group consisting of: annular shape, D-formedshape, open ring, C-formed shape.
 2. The device of claim 1, wherein saidannulus attachment is at least partly loop shaped and adapted to beaffixed to the valve annulus, and wherein said extension is attached tosaid annulus attachment at a circumference of said annulus attachment.3. The device of claim 1, wherein said extension extends from theannulus attachment towards a coaptation line of said cardiac valve, andsaid extension crosses the cardiac valve at said coaptation line.
 4. Thedevice of claim 1, wherein said extension is adapted to penetrate saidcardiac valve at the cardiac valve annulus.
 5. The device of claim 1,wherein said annulus attachment comprises a loop that is positionablealong at least a portion of the cardiac valve annulus.
 6. The device ofclaim 1 wherein said actuator acts on said extension to change adistance between the actuator and the annulus attachment for saidaugmenting the natural pumping force of the heart.
 7. The device ofclaim 1, wherein said actuator is configured to act against the apex ofthe heart in order to support displacement of the cardiac valve.
 8. Thedevice of claim 1 wherein said annulus attachment is configured toimprove closure of cardiac valve leaflets during systole.
 9. The deviceof claim 1, wherein said actuator is timed to provide said mechanicalsupporting force in synchrony with a cardiac cycle.
 10. A medical deviceadapted to enhance intra-cardiac blood circulation of a heart of apatient by assisting pump action of said heart, said device comprising:an annulus attachment for fixating an end of said device to a cardiacvalve annulus, said annulus attachment connected to an actuator via anextension including a rod to apply a mechanical supporting force to thevalve annulus towards an apex of said heart during at least a portion ofsystole for augmenting a natural pumping force of the heart, and/or awayfrom said apex of said heart during at least a portion of diastole foraugmenting a natural filling of a ventricle of said heart; wherein saidannulus attachment is a cardiac valve intra-atrial or intra-ventricularanchor unit.
 11. The device of claim 9, wherein said annulus attachmentis at least partly loop shaped and adapted to be affixed to the valveannulus, and wherein said extension is attached to said annulusattachment at a circumference of said annulus attachment.
 12. The deviceof claim 9, wherein said extension extends from the annulus attachmenttowards a coaptation line of said cardiac valve, and said extensioncrosses the cardiac valve at said coaptation line.
 13. The device ofclaim 9, wherein said extension is adapted to penetrate said cardiacvalve at the cardiac valve annulus.
 14. The device of claim 9, whereinsaid annulus attachment comprises a loop that is positionable along atleast a portion of the cardiac valve annulus.
 15. The device of claim 9,wherein said axial actuator acts on said extension to change a distancebetween the axial actuator and the annulus attachment for saidaugmenting the natural pumping force of the heart.
 16. The device ofclaim 9, wherein said axial actuator is configured to act against theapex of the heart in order to support displacement of the cardiac valve.17. The device of claim 9, wherein said annulus attachment is configuredto improve closure of the cardiac valve leaflets during systole.
 18. Thedevice of claim 9, wherein said axial actuator is timed to provide saidmechanical supporting force in synchrony with the cardiac cycle.
 19. Amedical device adapted to enhance intra-cardiac blood circulation of aheart of a patient, said device including a control unit activelycontrolling pump action by active controlled support of pump action ofsaid heart, said device comprising an annulus attachment for fixating anend of said device to a cardiac valve annulus, said annulus attachmentconnected to an actuator controlled by said control unit to apply amechanical supporting force to the valve annulus towards an apex of saidheart during at least a portion of systole for augmenting a naturalpumping force of the heart, and/or away from said apex of said heartduring at least a portion of diastole for augmenting a natural fillingof a ventricle of said heart.